Qualicheck 1+ — Class III medical device recall Z-0608-2013
Terminated recall by Radiometer America Inc, reported 2013-01-02, distributed in KY, NC, NY. The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyz
| Recall number | Z-0608-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Westlake, OH, United States |
| Recall initiated | 2006-06-06 |
| Classified | 2012-12-21 |
| Reported by FDA | 2013-01-02 |
| Terminated | 2013-02-05 |
| Distributed | KY, NC, NY |
| Quantity | 840 ampules |
| Lot numbers | R0040, R0042 |
| Model numbers | 944-042 |
| Expiration dates | 2008-02-20, 2008-04-20 |
Product
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Reason for recall
The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45.
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-0608-2013. 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.