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Abbott Laboratories Recall 90692

Description: ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27

Abbott Laboratories Recall 90692 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1660-2022
Event ID90692
Event DescriptionARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Product TypeDevices
DistributionNationwide
Quantity2451 kits of 100 tests
Recall ReasonOne lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
Device Classification20220907
Device Code InfoUDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22
Center Classification Date20220830
Recall Initiation Date20220726
Recalling FirmAbbott Laboratories
Initial Notification Letter
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