FDA Device recall Z-0641-2013
Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: Wh…
- FDA Device
- Class III
- terminated
- Published 2013-01-16
On 2013-01-16 the FDA classified a Class III recall of Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: Wh… by Siemens Healthcare Diagnostics, citing 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¿….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0641-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-11-21 |
| Published | 2013-01-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Reason
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).
Identifiers
| code_info | Carton/Bottle Lot Number: C0099091C P0099091C C0100101F P0100101F C9101022I P9101022I C0103042D P0103042D C0106062E P0106062E |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0641-2013%22
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