Recall record at a glance
| Official record | Z-1923-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Greiner Bio-One North America, Inc. |
| Report date | Jun 15, 2016 |
| Recall initiation date | Apr 26, 2016 |
| Quantity | 250,800 pieces (209 cases) |
| Location | Monroe, NC, United States |
Official product description
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
Why the product was recalled
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.
Distribution information
Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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