Piccolo Chemistry Analyzer software version 6.121 with… recallZ-2287-2008 · Abaxis Inc · initiated Apr 21, 2008
Terminated All recalls posted in September 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abaxis Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2287-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 21, 2008
- Posted by the FDA
- Sep 17, 2008
- Recalling firm
- Abaxis Inc
- Quantity
- 237 kits
- Product code
- JLB
- FDA submissions
- K992140
- Distribution
- Product was distributed Worldwide.
Product description
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.
Code information (models, lots, serial numbers)
software version 6.121 with Electrolyte Panel Lot #8041AC5, expiration date 2009-01-21
Other devices under the same FDA submission
5 devices cleared under K992140 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Piccolo Comprehensive Metabolic Panel 400-0028Abaxis, Inc. · Mercuric Thiocyanate, Colorimetry, Chloride7 reports
- Piccolo MetLyte 8 Panel 400-0023Abaxis, Inc. · Mercuric Thiocyanate, Colorimetry, Chloride1 report
- Piccolo Renal Function Panel 400-0027Abaxis, Inc. · Phosphomolybdate (Colorimetric), Inorganic Phosphorus1 report
- Piccolo Basic Metabolic Panel Plus 400-0031Abaxis, Inc. · Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase1 report
- Piccolo AmLyte 13 400-0041Abaxis, Inc. · Nadh Oxidation/Nad Reduction, Ast/Sgot1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 48709).
- Z-2286-2008 · TerminatedPiccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot #8111AA5 , Model Number 400-1028 in polyfoil pouch. Piccolo Comprehensive Metabolic Panel is a s…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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