Dimension¿ CREA — Class II medical device recall Z-2741-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-09-16, distributed nationwide. Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results u
| Recall number | Z-2741-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2015-07-15 |
| Classified | 2015-09-05 |
| Reported by FDA | 2015-09-16 |
| Terminated | 2017-03-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DZ, EC, EG, ES, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IS, IT, JO, JP, KR, KW, LB, LK, LT, LV, MA, MX, MY, NI, NL, NO, NP, NZ, OM, PE, PH, PK, PL, PT, PY, QA, RS, SA, SG, SI, SK, SV, TH, TN, TW, UY, VE, VN, ZA |
| Lot numbers | 14177BB, 14212BD, 14234BH, 14261BC, 14280BA, 14301BB, 14321AC, 14346AC, 15012AA, 15042BA, 15054AB, 15076BA, 15091BA, 15125BA, 15125BB, 15141AA, BA5293, BA6026, BA6027, BA6111, BA6112, DA5258, DB5195, EA5233, EA5315, EA5316, EB6047, FA5211, FA5275, FA5351, FA5352, FA6006, FB6139, GA5342, GA6097, GB6076 |
| Expiration dates | 2015-06-26, 2015-07-14 |
Product
Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine.
Reason for recall
Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemolysis exceeds 200 mg/dL and 300 mg/dL respectively.
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-2741-2015. 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.