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.
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 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:
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