Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel Lot #8041AC5, model number 400-1022 in polyfoil pouch. Piccolo Electrolyte Panel is a single-use, self-contained reagent disk intended for use with the Piccolo and PiccoloXpress chemistry analyzers, for in vitro qualitative determination.
FDA Recall Z-2287-2008 · Posted 2008-09-17
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Recalling FirmAbaxis Inc
Recall StatusTerminated
Product CodeJLB
Date Initiated2008-04-21
Date Terminated2011-04-26
Product Quantity237 kits
Reason for Recall
The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples
Firm Action
The firm issued a notification letter to its consignees on April 21, 2008. The firm intends to follow up with phone calls and provide a software upgrade for the products. Contact Abaxis Customer Service at 1-510-675-6500 for assistance.
Root Cause
Process control
Distribution Pattern
Product was distributed Worldwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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