Siemens CLINITEK Atlas Positive and Negative Control recall
Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS¿ Automated…
Why was Siemens CLINITEK Atlas Positive and Negative Control recalled?
When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).
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?
Carton/Bottle Lot Number: S9093061A P9093061A S9094081A P9094081A S0097091C P0097091C S9093061A P9093061A S9094081A P9094081A S0097091C P0097091C S0100101B P0100101B S0103042A P0103042A S0103042H P0103042H S0106062A P0106062A S9101022A P9101022A S9101022B P9101022B S9105052A P9105052A
- Product
- Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS¿ Automated…
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 6466
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
- Recall date
- January 16, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)