Ortho-Clinical Diagnostics Recalls VITROS Phenobarbital Slides Due to Accuracy Issues
Ortho-Clinical Diagnostics is recalling VITROS Phenobarbital Slides because they may produce inaccurate, positively biased patient results that quality controls might miss.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may produce inaccurate diagnostic results (positively biased values) which could lead to incorrect patient management. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ortho-Clinical Diagnostics (OCD) is recalling VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. These products are used for the quantitative measure of phenobarbital concentration in serum and plasma. The recall affects 11,164 domestic units and 594 foreign units distributed worldwide, including the United States, Puerto Rico, and various international markets.
The recall was initiated after OCD received customer complaints regarding intermittent imprecision, outliers, or shifts in accuracy, as well as control fluid values falling outside expected intervals. OCD's investigation confirmed that the slides could produce positively biased values for patient samples. The company noted that these inaccuracies may not be detected by standard quality control fluids.
The affected lots are identified by specific generation and coating numbers with expiration dates ranging from March 2013 to February 2014. Specifically, the recall includes lots with GEN 38 (Coating 0060), GEN 39 (Coating 0062), GEN 40 (Coating 0063), and GEN 41 (Coating 0064). Users of these products should stop using the affected slides and contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- All Lot Numbers containing: GEN 38
- Coating No. 0060
- Expiration Date Range 03/01/13 through 07/01/13
- GEN 39
- Coating No. 0062
- Expiration Date Range 07/01/13 through 09/01/13
- GEN 40
- Coating No. 0063
- Expiration Date Range 10/01/13 through 12/01/13
- GEN 41
- Coating No. 0064
- 0062
- 0063 or 0064.].
Distribution
Related recalls
Same manufacturer · Ortho-Clinical Diagnostics
See all →- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
Same hazard · inaccurate results
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
Similar recalls
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides
FDA (Devices) · 2013-11-27
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Chemistry Products PHYT Slides
FDA (Devices) · 2018-01-03
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Phenytoin Slides Due to Potential Bias
FDA (Devices) · 2014-10-08
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Slide Dispense Cartridges
FDA (Devices) · 2013-11-27
- ModerateOrtho-Clinical Diagnostics Recalls VITROS TBIL Slides for Dispense Issues
FDA (Devices) · 2013-11-27
- SevereOrtho-Clinical Diagnostics Recalls VITROS TRIG Slides Due to Biased Results
FDA (Devices) · 2014-12-31