Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack… recallZ-1155-2010 · Abaxis Inc · initiated Nov 16, 2009
Terminated All recalls posted in March 2010
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
Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.
FDA root cause category: Labeling mix-ups
What the company is doing
An "URGENT: PRODUCT RECALL NOTICE" dated November 16, 2009, was sent to customers. The notification described the product, issue/impact, and the action/resolution to be taken by the customers. The customers are to discontinue use of the specified lot, contact Abaxis for immediate replacement and complete and return the enclosed Response form within 5 working days. They may fax the form to Abaxis Technical Support at 1-510-315-3140. The customer are requested to ensure all laboratory staff are informed about this notice and retain this notification as a part of their laboratory Quality System documentation. The firm is currently contacting all direct shipment customers. If you have any questions regarding this Product Recall Notice, please contact Abaxis Medical Technical Support at 800-822-2947, extension 6505, or at [email protected].
Recall details
- Recall number
- Z-1155-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 16, 2009
- Posted by the FDA
- Mar 16, 2010
- Recalling firm
- Abaxis Inc
- Quantity
- 1010 boxes
- Product code
- JFY
- FDA submissions
- K942782
- Distribution
- Worldwide distribution: USA and Canada, EU and Asia
Product description
Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufactured by Abaxis Inc., Union City, CA Medical device for use in the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline Phosphatase (ALP), aspartate aminotransferase, calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen in heparinized whole blood, heparinized plasma or serum.
Code information (models, lots, serial numbers)
Lot number 9284AC2, accidentally labeled as 9285AC2, catalog number 400-0028, expiration date 7/9/2010
Other devices under the same FDA submission
5 devices cleared under K942782 — 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
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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