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Clark Laboratories, Inc. Recall 89088

Description: Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440

Clark Laboratories, Inc. Recall 89088 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0382-2022
Event ID89088
Event DescriptionBartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440
Product TypeDevices
DistributionOH, UT
Quantity53 units
Recall ReasonContamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
Device Classification20211222
Device Code InfoLot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065
Center Classification Date20211215
Recall Initiation Date20211011
Recalling FirmClark Laboratories, Inc.
Initial Notification Letter
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