Pacheco, CA, United States
Biocare Medical, LLC recalls
5 recalls recorded since 2018, most recently on 25 September 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)1
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 September 2024
- Reason
- Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated.
- Distribution
- US Nationwide distribution in the states of MA, AZ, CT, NY, FL, NC, IN, IL, MO, CO, TX, CA, MI, PR, PA, MD, AL, OH, KY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0315-2025
- intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Ch
Terminated Class II Medical devices
- Recall started
- 25 February 2021
- Terminated
- 31 January 2023
- Reason
- Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in the instrument hitting end stops or running into other components on the working deck. This could also result in wash buffer being dispensed on random locations.
- Distribution
- US: AL, AZ, CA, CT, FL, IL, MA, MD, MN, NC, OH, OR, PA, WA, WY OUS: Germany, Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1333-2021
- BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
Terminated Class II Medical devices
- Recall started
- 10 October 2019
- Terminated
- 2 December 2020
- Reason
- Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosis.
- Distribution
- US: TX, MA, TN, MO, IN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2291-2020
- 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
Terminated Class II Medical devices
- Recall started
- 24 April 2018
- Terminated
- 14 July 2020
- Reason
- Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.
- Distribution
- CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2360-2018
- Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S
Terminated Class II Medical devices
- Recall started
- 15 March 2018
- Terminated
- 22 April 2020
- Reason
- Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
- Distribution
- Worldwide Distribution - Unites States Nationwide in the states of NY AND FL and the countries of: Morocco and Italy
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3198-2018
- URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062AA, Package Type: Bot
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.