Company: Baxter Healthcare, LLC
Date of Enforcement Report:4/6/06
Class:Il
PRODUCT
a) Brand Name: RapidLab 1200 System, Model 1240,
Part Number 05060298; All RapidLab 1200 Systems with
Software Versions 1.0, 1.01, or 1.02. — Common Name: Blood gases,
electrolyte and blood pH test system, Recall # Z-0682-06;
b) Brand Name: RapidLab 1200 System, Model 1245, Part Number 05061537;
All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. —
Common Name: Blood gases, electrolyte and blood pH test system,
Recall # Z-0683-06;
c) Brand Name: RapidLab 1200 System, Model 1260, Part Number 05062460;
All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. —
Common Name: Blood gases, electrolyte and blood pH test system,
Recall # Z-0684-06;
d) Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769;
All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. —
Common Name: Blood gases, electrolyte and blood pH test system,
Recall # Z-0685-06
REASON
When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or 1.02. The correlation feature applies user-defined slope and offset parameters each time stored test results are recalled to the display.
CODE
All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer Healthcare, LLC (Diagnostics Division), Tarrytown, NY, by E-mails on January 20, 2006.
Manufacturer: Bayer Healthcare, LLC (Diagnostics Division), Norwood, MA, firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
515 units
DISTRIBUTION
Nationwide and Internationally
