Siemens Dade Actin Activated Cephaloplastin Reagent Recalled for Out-of-Range Results
Siemens Healthcare Diagnostics is recalling Dade Actin Activated Cephaloplastin Reagent because assay controls are out of assigned ranges, potentially causing inaccurate APTT test results.
What this means for you
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 where inaccurate test results could lead to incorrect medical decisions, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dade Actin Activated Cephaloplastin Reagent, a liquid rabbit brain cephalin reagent used for activated partial thromboplastin time (APTT) and other coagulation procedures. The recall involves specific lot numbers and expiration dates distributed worldwide, including the United States, Puerto Rico, Barbados, and Mexico.
The recall was initiated because recovery for assayed controls is out of assigned ranges. The source text notes that a drift greater than 3 seconds in the normal APTT range and/or greater than 15% in the pathological range has been observed. Consequently, patient samples with recoveries close to medical decision points could exhibit deviations up to 4 seconds for the normal range and up to 33% for the pathological range.
Healthcare facilities and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 27,501
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 (15)
- Catalog Number B4218-1
- Material Number 10445709
- lot numbers 557128
- 557129
- 557130
- 557131
- 557132
- 557133
- 557134
- 557135
- 557140
- 557141
- expiration dates:10/31/2015
- 11/21/2015
- 2/16/2016
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · inaccurate results
See all →- 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
- Highepoc BGEM BUN Test Card for epoc Blood Analysis System
FDA (Devices) · 2026-05-06
- HighAbbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
FDA (Devices) · 2026-05-06