Hazard

Calibration Error recalls

152 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 152
Critical: 0
Severe: 8
Most recent: 2026-07-22

Of the 152 calibration error recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (5%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all calibration error recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

51–75 of 152

HighFDA (Devices)·Z-1284-2022·2022-07-06
Tacrolimus Calibrator Set Recalled for Inaccurate Immunoassay Quantitation
The QMS Tacrolimus Calibrator Set is recalled because calibrators recovered 82-94% of target values, causing inaccurate (over-quantitated) patient drug test results. This affects healthcare facilities in 20 US states and 9 countries.
Product
QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-1097-2022·2022-05-25
Randox CK MB Calibrator recalled due to calibration inaccuracy affecting test results
Randox Laboratories has recalled the CK MB Calibrator (lot 4410CK) because it requires recalibration. When used without proper realignment, the calibrator produces test results approximately 6% higher than actual values.
Product
CK MB Calibrator, Catalogue Number CK2393
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0415-2022·2021-12-29
Surgical Suction Instruments Recalled for Calibration Defect Risk
Acclarent's TruDi NAV Suction Instruments may be incorrectly calibrated, affecting surgical navigation accuracy. If undetected, the error could cause tissue damage, arterial injury, or nerve damage.
Product
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-0271-2022·2021-12-01
Abbott ARCHITECT Analyzer Software Issues May Cause Inaccurate Test Results
Abbott is recalling approximately 20,994 ARCHITECT i1000SR, i2000SR, and i2000 automated analyzers due to 12 software-related issues in version 9.41 and earlier that may produce inaccurate diagnostic test results.
Product
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
Category
Medical Device
Distribution
50 states
HighFDA (Devices)·Z-0274-2022·2021-12-01
Freelite Human Lambda Free Kit Recalled for Calibration Curve Inaccuracy
The Binding Site Group recalled 2,254 Freelite Human Lambda Free Kits due to calibration curve issues that may produce higher-than-expected activity readings and affect measurement accuracy.
Product
Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-0033-2022·2021-10-13
Medical Device Calibrator Kit Recall for Incorrect Labeling
FDA recalls Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit due to incorrectly labeled calibrator vials in Lot 00681Y600. The labeling error prevents the instrument from completing calibration successfully.
Product
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2426-2021·2021-09-15
Medical diagnostic kit requires more frequent calibration than Instructions stated
The Instructions for Use for Siemens' Atellica IM BR 27.29 Test Kit incorrectly specified a 10-day calibration interval instead of 3 days. The manufacturer has updated the instructions for all kit lots.
Product
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2099-2021·2021-07-28
Medical Device Calibration Standard Assigned Incorrectly in NEFA CAL Kit
Randox Laboratories recalls NEFA CAL IVD calibration standard kits (Batch 544642) due to incorrectly assigned calibration values that could cause measurement errors up to 8% in quality control and patient test results.
Product
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1906-2021·2021-06-30
SARS-CoV-2 IgG II Calibrator Results Potentially Multiplied by 1000
Beckman Coulter's Access SARS-CoV-2 IgG II Calibrator may return test results inflated by up to 1000-fold due to software errors, potentially misrepresenting patient immune status.
Product
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
Category
Medical Device
Distribution
31 states
ModerateFDA (Devices)·Z-1563-2021·2021-05-19
Randox Calibration Serum Level 3 Recalled for Bilirubin Bias
Randox Laboratories is recalling 98 kits of Calibration Serum Level 3 (CAL 3) due to a positive bias in bilirubin measurements.
Product
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-0476-2021·2020-12-02
Luminex Recalls Verigene Processor SP Due to Unapproved Service Fixtures
Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate and verify the devices.
Product
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0283-2021·2020-11-04
Intuitive Surgical Recalls da Vinci Xi Endoscope Controller for Calibration Error
Intuitive Surgical is recalling one da Vinci Xi Endoscope Controller because improper calibration may cause the endoscope tip to reach higher temperatures, potentially leading to thermal tissue injury.
Product
da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform mi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2792-2020·2020-08-19
Brainlab Curve Navigation Stations Recalled for Incorrect Manufacturer Calibration
Brainlab AG is recalling 18 Curve navigation stations due to incorrect manufacturer calibration. The devices were distributed in the US and internationally.
Product
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2431-2020·2020-07-01
Siemens Atellica CH Chemistry Calibrator Recalled for Calibration Errors
Siemens Healthcare Diagnostics is recalling Atellica CH Chemistry Calibrators due to observed calibration errors in Total and Direct Bilirubin assays.
Product
Atellica CH Chemistry Calibrator
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2430-2020·2020-07-01
Siemens ADVIA Chemistry Calibrator Recalled for Calibration Errors
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Calibrator lots 534177 and 534179 due to observed calibration errors in Total and Direct Bilirubin assays.
Product
ADVIA Chemistry Calibrator
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0824-2020·2020-01-29
Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues
Acclarent, Inc. is recalling TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.
Product
TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0825-2020·2020-01-29
Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues
Acclarent, Inc. is recalling specific lots of TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.
Product
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0581-2020·2019-12-04
Siemens Atellica CH 930 Analyzer Recalled for Calibration Error
Siemens Healthcare Diagnostics is recalling 1,432 Atellica CH 930 Analyzers due to a potential calibration error that may cause results to be five times higher than expected.
Product
Atellica CH 930 Analyzer
Category
Medical Device
Distribution
35 states
ModerateFDA (Devices)·Z-2443-2019·2019-09-11
CareFusion Alaris EtCO2 Capnographs Recalled for Calibration Error
CareFusion 303, Inc. is recalling 76 Alaris EtCO2 capnographs because they may have been calibrated with a lower-than-specified CO2 concentration.
Product
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-2184-2019·2019-08-14
Ortho VITROS 5,1 FS Chemistry System Recalled for Software Calibration Issue
Ortho Clinical Diagnostics is recalling 55 VITROS 5,1 FS Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
Product
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0228-2019·2018-10-31
bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue
bioMerieux is recalling 516 BACT/ALERT VIRTUO systems with R2.0 firmware because a service feature may leave calibration standards in incorrect locations, potentially causing anomalies.
Product
BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0229-2019·2018-10-31
bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue
bioMerieux is recalling 151 BACT/ALERT VIRTUO systems with R2.0 firmware because a software feature may allow calibration standards to be left in incorrect positions, potentially causing anomalies.
Product
BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2331-2018·2018-07-04
BioMerieux Recalls VIDAS FSH Assay Kits Due to Calibration Issues
BioMerieux SA is recalling VIDAS FSH assay kits due to invalid calibration errors. The recall affects 59 units distributed in the U.S.
Product
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-1322-2018·2018-04-18
Clinical Diagnostic Systems Recalls VITROS TSH Reagent Packs Due to Calibration Issues
Clinical Diagnostic Systems is recalling specific lots of VITROS TSH Reagent Packs because they may generate higher-than-expected calibrator signals, potentially causing calibration curves to fall outside quality parameters.
Product
VITROS Immunodiagnostic Products TSH Reagent Pack
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1183-2018·2018-04-04
Quidel Recalls Sofia 2 Analyzers Due to Calibration Error
Quidel is recalling 482 Sofia 2 Analyzers because a manufacturing error may cause calibration failure or incorrect test results.
Product
Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.
Category
Medical Device
Distribution
0 states