Clotting time reagent recalled after lots were made with double preservative
Instrumentation Laboratory is recalling 4,506 units of HemosIL SynthAFax partial thromboplastin time reagent because the recalled lots were manufactured with double the preservative concentration.
What this means for you
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: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites a doubled preservative concentration with no stated consequence.
Plain-English summary
HemosIL SynthAFax, a partial thromboplastin time test reagent, is being recalled by Instrumentation Laboratory.
The recalled lots were manufactured with double the amount of preservative concentration.
The record lists 4,506 units, part number 0020007400, UDI 08426950087649, across lots including N0542231 (expiry 2026-06-30) and N0250088 (expiry 2027-04-30). Domestic distribution covered California, Colorado, Florida and New York, with foreign distribution to a range of other countries. The FDA has classified the action as Class III, its least serious category.
The record describes a formulation deviation and states no consequence or reported injuries. Laboratories should follow the firm's instructions.
The recalled product
- Product
- HemosIL SynthAFax. Partial Thromboplastin Time Tests.
- Manufacturer
- Instrumentation Laboratory
- Affected units
- 4,506
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 (5)
- Part No. 0020007400
- UDI: 08426950087649
- Lot No. (Exp. Date) N0542231(2026-06-30)
- N0250088(2027-04-30
- N0452249 (2027-06-30).
Distribution
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