The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0020-2014·Announced 2013-10-23

Abbott Clinical Chemistry Phosphorus Reagent Recalled for Incorrect Expiration Dates

Abbott Laboratories is recalling specific lots of Clinical Chemistry Phosphorus Reagent because the supplier assigned incorrect expiration dates to the product.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error (incorrect expiration dates) without reporting any illnesses, injuries, or adverse health consequences. This aligns with the rubric for minor labeling errors or low-risk issues.

Plain-English summary

Abbott Laboratories, Inc. is recalling specific lots of Clinical Chemistry Phosphorus Reagent. The product is used for the quantitation of phosphorus in human serum, plasma, or urine. The recall involves 7,213 units distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous countries across Europe, Asia, Africa, and the Americas.

The recall was initiated because the supplier assigned incorrect expiration dates to the affected reagent lots. The specific lots involved are 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13. These lots are associated with List Numbers 7D71-22 and 7D71-31.

Healthcare facilities and laboratories should check their inventory for these specific lot numbers and stop using the affected product. Users should contact Abbott Laboratories for further instructions on how to return or dispose of the recalled units.

The recalled product

Product
Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
Manufacturer
Abbott Laboratories, Inc
Category
Medical Device — In Vitro Diagnostic Reagent
Hazard
Affected units
7,213

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • For List Number: 7D71-22
  • Lot Numbers 64736UN12 (Exp Date on Label is 14 JAN 2014)
  • 03991UN13 (Exp Date on Label is 01 APR 2014)
  • and 51611UN13 (Exp Date on Label is 13 JUL 2014). For List Number: 7D71-31

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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