Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
Summary
The FDA issued a Class III for Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro by Stanbio Laboratory, LP. Reason: Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values..
Details
Source
Device Recall
External ID
Z-2203-2021
Action Date
2021-08-11
Status
Terminated
Category
device
Product Description
Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
Lot/Code Info: Catalog Number/Product Description: CHB2440180/Cardinal Health ¿-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX Device Identifier: 10885380173141 Lot Numbers: 164986;
Quantity Affected: 93 units
Reason for Recall
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Distribution
Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-12
Company
Boerne, TX
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 113 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stanbio Laboratory, LP has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stanbio Laboratory, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stanbio Laboratory, LP have FDA actions?
Stanbio Laboratory, LP has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2203-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29