Z-0020-2014Class II

Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in...

Name: Z-0020-2014 Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in...
Creator: Abbott Laboratories, Inc
Published: 2013-08-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-08-12 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories, Inc began a recall of Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine on 2013-08-12. FDA classified it as Class II and gives the reason as "Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0020-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-12
Posted: 2013-10-17
Terminated: 2015-04-06
Recalling firm: Abbott Medical
Product: Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
Product code: CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Reason for recall: Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm, Abbott Laboratories, sent a "PRODUCT CORRECTION" letter dated August 12, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to update existing inventory and manually track the implanted lots with the corrected expiration dates listed in the letter; retain a copy of letter and if you have forwarded any of the lots listed to another laboratory, provide a copy of the letter to them. If you or any of your healthcare providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 1-877-4ABBOTT (422-2688). Customers outside the U.S., please contact your local area customer service.
Quantity in commerce: 7213
Distribution: Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Austria, Australia, Azerbaijan, Bangladesh, Bahamas, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Burkina, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, El Salvador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania ,Mexico, Moldova, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Tajikistan, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, United Arab Emirates, United Kingdom, Uruguay and Vietnam.
Product codes and lots: 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, Lot Numbers 74805UN12 (Exp Date on Label is 14 JAN 2014) and 03992UN13 (Exp Date on Label is 01 APR 2014).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0020-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0020-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-23	2013-10-17

Product code CEO

K981759Class IPhosAbbott Laboratories / cleared 1998-06-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)