Reported Sep 16, 2015 · Terminated
Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- 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.
- Lot codes and dates
- Dimension CREA Lot Numbers
DB5195FA5211EA5233DA5258FA5275BA5293EA5315EA5316GA5342FA5351FA5352FA6006BA6026BA6027EB6047GB6076GA6097BA6111
- BA6112 FB6139 with expiration dates
2015-07-142015-07-302015-08-212015-09-152015-10-022015-10-202015-11-112015-11-122015-12-082015-12-172015-12-182016-01-062016-01-262016-01-272016-02-162016-03-162016-04-062016-04-202016-04-212016-05-20
- Dimension Vista CREA Lot Numbers
14177BB14212BD14234BH14261BC14280BA14301BB14321AC14346AC15012AA15042BA15054AB15076BA15091BA15125BB15125BA15141AA
- with expiration dates
2015-06-262015-07-312015-08-222015-09-182015-10-072015-10-282015-11-172015-12-122016-01-122016-02-112016-02-232016-03-162016-03-312016-05-042016-05-042016-05-22
- Dimension CREA Lot Numbers
- Amount recalled
- Total number Dimension Vista - 32,165, Dimension - 238,634
Where it was sold
- Nationwide
- GA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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