Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine… — Class III medical device recall Z-0636-2013
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-0636-2013 |
|---|---|
| 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 | 6,466 |
| Lot numbers | P0097091C, P0100101B, P0103042A, P0103042H, P0106062A, P9093061A, P9094081A, P9101022A, P9101022B, P9105052A, S0097091C, S0100101B, S0103042A, S0103042H, S0106062A, S9093061A, S9094081A, S9101022A, S9101022B, S9105052A |
| Model numbers | 5019 |
Product
Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS¿ Automated urine Chemistry Analyzer and CLINITEK ATLAS¿ 10 reagent Pak, CLINITEK ATLAS¿ Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas.
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-0636-2013. 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.