Coagulation reagent recalled over potential for microbial contamination
Instrumentation Laboratory is recalling 7,720 units of a coagulation reagent used for evaluating the intrinsic pathway and monitoring heparin therapy over potential microbial contamination.
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: Scored 3 under the risk-of-harm criterion: the record cites potential microbial contamination of a laboratory reagent, and no injuries are reported.
Plain-English summary
The product, described in the record as used for the evaluation of the intrinsic coagulation pathway, the APTT substitution test and the monitoring of heparin therapy, is being recalled by Instrumentation Laboratory.
The reason given in the enforcement record is the potential for microbial contamination.
The record lists 7,720 units, part number 0020006800, UDI-DI 08426950078920, from lot N1136730 with an expiration date of 12/31/2025. Distribution was worldwide, including nationwide in the United States across California, Florida, Illinois, Minnesota, Mississippi, Nebraska, Ohio, Texas and Wisconsin. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Laboratories should quarantine the affected lot and follow the firm's instructions.
The recalled product
- Product
- The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
- Manufacturer
- Instrumentation Laboratory
- Affected units
- 7,720
Distribution
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