Reported Aug 15, 2012 · Terminated
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing…
Radiometer America 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: Radiometer America Inc · 810 Sharon Dr · Westlake, OH · 44145-1521
Is this the product you have?
- The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are
- intended for the in Vitro testing of-Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are
- intended for the in Vitro testing of-Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter
- Lot codes and dates
- ABL725
441R0086N008441R0292N010
- and 441R0520N009U ABL 735
441R0050N001441R0231N0009441R0234N0010441R0292N0009441R0303N010441R0340N004441R0343N010and 441R0522N008
- ABL725
- Amount recalled
- 6854 ABL 7xx units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t
This product could cause temporary or reversible health problems — stop using it.
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