Device recall: Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
Class III FDA enforcement event 88323. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Stanbio Laboratory, LP started this device recall on 12 Jul 2021. The firm address in the FDA record is in Boerne, TX. FDA put the recall in Class III. FDA event 88323 has 5 product records. The first FDA enforcement report date is 11 Aug 2021. The record gives the status Terminated, with the termination date 29 Mar 2022.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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,…
Recalling firm
Stanbio Laboratory, LP, Boerne, TX.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2199-2021 | Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. | 7,108 products | Class III | Terminated | 11 Aug 2021 |
| Z-2200-2021 | Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent. | 200 units | Class III | Terminated | 11 Aug 2021 |
| Z-2201-2021 | Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent. | 100 units | Class III | Terminated | 11 Aug 2021 |
| Z-2202-2021 | Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. | 3,940 units | Class III | Terminated | 11 Aug 2021 |
| Z-2203-2021 | Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent. | 93 units | Class III | Terminated | 11 Aug 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class III
- 3%
- Product records in this event
- 5Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Oct 2023 | STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values. | Device | Class II | 1 |
| 16 Mar 2022 | Separation Technology Creamatocrit Plus, Catalog Number: 100-146 | Device | Class II | 1 |
| 13 Feb 2018 | RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) | Device | Class II | 1 |
| 8 Feb 2018 | Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2199-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 88323. https://recallregister.com/fda/iii/88323/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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,…
- What quantity of product is in FDA event 88323?
- The event has 5 product records. The first record gives this quantity:
7,108 products
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 3% of the 900 device events that started in 2021 are in Class III.