FDA Device recall Z-0639-2013
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistr…
- 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 only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistr… 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-0639-2013 |
| 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 only) Catalog Number: 1364M 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: CP0099091B P0099091B C0100101G P0100101G C0103042E P0103042E |
|---|
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-0639-2013%22
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