Reported Aug 15, 2012 · Terminated
The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples…
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 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
- ABL800 BASIC754R0406N012U
- ABL800 BASIC with AutoCheck
2,015 of 2,015 codes
754R0742N006754R0467N002754R0466N008754R0467N001754R0433N011754R0434N001754R0437N005754R0437N006754R0437N007754R0436N004754R0437N001754R0436N003754R0436N005754R0436N006754R0437N003754R0437N002754R0432N003754R0432N004754R0432N005754R0436N002754R0467N003754R0276N001754R1306N002754R1306N003754R1308N003754R1308N005754R1308N006754R1309N001754R1309N005754R1309N006754R1309N007754R1310N001754R1310N002754R1310N003754R1310N004754R1310N005754R1310N006754R1310N007754R1311N001754R1311N002754R1311N003754R1311N004754R1311N006754R1312N001754R1312N003754R1312N005754R0294N008754R1191N002754R1191N003754R1191N004754R1191N005754R0400N010754R0401N001754R0400N004754R0400N005754R0387N012754R0886N003754R0886N004754R0306N001754R0306N002
- And 754R0415N008 ABL800 FLEXAnd 754R0255N007U
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
- ABL800 FLEX with AutoCheck75
241 of 241 codes
754R0445N008754R0445N009754R0445N010754R0445N011754R0445N012754R0781N006754R0792N001754R0792N005754R0792N008754R0915N009754R0925N001754R0588N010754R1366N004754R1343N005754R1343N004754R1337N004754R1273N004754R1256N003754R1236N002754R1192N004754R1158N001754R1158N002754R1155N001754R1146N005754R1083N006754R1083N007754R0715N008754R1014N006754R1014N007754R0237N012754R1134N006754R0349N002754r0357n003754R0757N003754R0757N004754R0761N005754R0761N006754R0761N007754R0762N001754R0762N002754R0724N006754R0722N007754R0722N008754R0722N010754R0724N001754R0724N002754R0724N003754R0724N007754R0472N006754R0715N001754R0715N002754R0715N003754R0715N004754R0715N005754R0715N006754R0715N007754R0399N010754R0397N002754R0397N004754R0397N008
- Amount recalled
- 11929 ABL 8xx 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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