Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive… — Class III medical device recall Z-0637-2013
Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2013-01-16, distributed nationwide. When these lots of control material are reconstituted, the positive control solution leukocyte result may beco
| Recall number | Z-0637-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics Inc, Norwood, MA, United States |
| Recall initiated | 2012-11-21 |
| Classified | 2013-01-04 |
| Reported by FDA | 2013-01-16 |
| Terminated | 2014-11-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AW, BR, BS, CA, DK, HK, IN, MX, NZ, SG, TH |
| Quantity | 16,711 |
| Lot numbers | C0097091E, C0099091D, C0100101D, C0100101E, C0103042B, C0103042G, C0106062D, C9093061C, C9094081J, C9101022E, C9101022H, C9101022J, C9105052C, P0097091E, P0099091D, P0100101D, P0100101E, P0103042B, P0103042G, P0106062D, P9093061C, P9094081J, P9101022E, P9101022H, P9101022J, P9105052C |
| Model numbers | 1364 |
Product
Siemens Chek-Stix Combo Pak Catalog Number: 1364 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 for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0637-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.