FDA Medical Device Recalls (openFDA)
Abbott Molecular: 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.
- Recall number
- Z-1148-2010
- Recalling firm
- Abbott Molecular
- 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.
- Status
- Terminated
- Initiated
- 2010-01-22
- Posted
- 2010-03-16
- Terminated
- 2012-01-29
- Reason
- The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.
- 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
- 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.
- Lot, serial or model codes
- list 07J02-003, part number 32-801230, lot numbers 420063 and 418669
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KEO
- Firm FEI
- 3005248192
- Firm city
- Des Plaines
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28