Z-1148-2010

Paraffin Pretreatment Reagent Kit III; each kit contains the following: 5 x 50 mL Pretreatment Solution (1N...

Name: Z-1148-2010 Paraffin Pretreatment Reagent Kit III; each kit contains the following: 5 x 50 mL Pretreatment Solution (1N...
Creator: Abbott Molecular
Published: 2010-01-22
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2010-01-22 / Terminated / root cause: packaging

FDA source

Abbott Molecular began a recall of Paraffin Pretreatment Reagent Kit III; each kit contains the following: 5 x 50 mL Pretreatment Solution (1N sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease... on 2010-01-22. The reason FDA records is "The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1148-2010
Status: Terminated
Initiated: 2010-01-22
Posted: 2010-03-16
Terminated: 2012-01-29
Recalling firm: Abbott Molecular, Inc.
Product: Paraffin Pretreatment Reagent Kit III; each kit contains the following: 5 x 50 mL Pretreatment Solution (1N sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer III (50 mM Tris base, pH 8.0 5 mM Calcium Chloride - 2H2O 0.1% SDS), 5 x 9.0 mg Protease III (Proteinase K, 35 <= x <= 38 Units/mg) 2 x 200 mL Protease Stop Solution (0.01N hydrochloric acid - HCl); Abbott Molecular Inc; list 07J02-003, part number 32-801230. invitro diagnostic.
Product code: KEO Formulations, Paraffin, All
Reason for recall: The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Abbott Molecular sent Field Correction Letter/Urgent Field Safety Notice letters dated 1/21/10 to the Paraffin Pretreatment Regent Kit customers on 1/22/10, informing them that the MSDA symbology for hazardous and corrosive material is missing from the Paraffin Pretreatment Regent Kit II and Paraffin Pretreatment Regent Kit III labels. The information is missing from the vial label, kit label and package insert. The letter listed the risk and safety statements that should be included in the package insert, and advised the customers should use the kits in accordance with the listed risk and safety statements. The accounts were instructed to review this information with laboratory personnel and retain the letter for future reference, making copies of the letter and placing them in each kit in stock. Any questions were directed to their local Abbott Molecular Representative. Abbott Molecular plans to telephone each customer to ensure that they have received the letter and have disseminated the information to their laboratory personnel.
Quantity in commerce: 17 kits
Distribution: Worldwide distribution: USA, Argentina, Austria, Belarus, Belgium, Canada, Colombia, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Kuwait, Lebanon, Lithuania, the Netherlands, Panama, Poland, Singapore, Slovenia, South Africa, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Vietnam.
Product codes and lots: list 07J02-003, part number 32-801230, lot numbers 420063 and 418669

Product code KEO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)