Drew Scientific Recalls Drew3-PAC Reagent Packs Due to Platelet Background Issues
Jas Diagnostics/Drew Scientific is recalling Drew3-PAC reagent packs because they may cause elevated platelet background during routine analyzer checks.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential inaccuracies in diagnostic testing (elevated platelet background) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Jas Diagnostics/Drew Scientific is recalling 7,691 units of the Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes diluent reagent (5L), enzymatic cleaner (750 mL), and a lysing reagent (125 mL). The recall covers specific lots with expiration dates in January 2018.
The recall was initiated because the reagent pack may result in elevated platelet background during the Drew3 Hematology Analyzer routine check. This issue could affect the accuracy of hematology testing results.
The affected products were distributed worldwide, including in the United States and various international locations. Users of these reagent packs should stop using them and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
- Manufacturer
- Jas Diagnostics/Drew Scientific
- Hazard
- Affected units
- 7,691
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 (11)
- Lot # 0825
- exp 01/06/2018
- Lot # 0826
- Lot # 0827
- Lot # 0828
- exp 01/21/2018
- Lot # 0829
- Lot # 0830
- Lot # 0831
- and Lot # 0832
- exp 01/21/2018.
Distribution
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