RecallReported October 21, 2026
Class I recall by Instrumentation Laboratory
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
FDA's enforcement report of October 21, 2026 lists a Class I recall by Instrumentation Laboratory of Bedford, MA. Product: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic. Status: Ongoing.
On the record
- Recalling firm
- Instrumentation Laboratory
- Location
- Bedford, MA
- Classification
- Class I
- Status
- Ongoing
- Recall number
- Z-0001-2027
- Product type
- Devices
- Recall initiated
- 2026-09-03
- Reported by FDA
- 2026-10-21
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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