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Terminated

4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate

FDA Recall Z-1923-2016 · Posted None

Recalling FirmGreiner Bio-One North America, Inc.
Recall StatusTerminated
Product CodeJKA
Date Initiated2016-04-26
Date Terminated2016-08-22
Product Quantity250,800 pieces (209 cases)

Reason for Recall

The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.

Firm Action

Greiner Bio-One North America, Inc. sent an Urgent Product Recall letter dated April 26, 2016, to all affected consignees. The letter requested that they stop distribution of the product and to provide Greiner with a list of their sub-accounts. The letter included a Product Disposition/Site Confirmation form which is to be returned to Greiner Bio-one. Consignees with questions were instructed to call 800-515-8112. For questions regarding this recall call 704-261-7823.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K971239GREINER VACUETTE BLOOD COLLECTION TUBEGreiner America, Inc. · 1997-05-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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