Bartels Legionella Urinary Antigen- an adjunct to recall: Contamination
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative…
Why was Bartels Legionella Urinary Antigen- an adjunct to recalled?
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065
- Product
- Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative…
- Recalling firm
- Clark Laboratories, Inc.
- Quantity
- 53 units
- Distribution
- OH, UT
- Recall date
- December 22, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)