Device recall: Sekisui Diagnostics Control Kit OSOM BVBLUE Bacterial Vaginosis
Class II FDA enforcement event 94024. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Mckesson Medical-Surgical Inc. Corporate Office started this device recall on 9 Jan 2024. The firm address in the FDA record is in Richmond, VA. FDA put the recall in Class II. FDA event 94024 has 5 product records. The first FDA enforcement report date is 27 Mar 2024. The record gives the status Ongoing.
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.
US Nationwide distribution in the states of AZ, PA and TX.
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA.
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-1311-2024 | Sekisui Diagnostics Control Kit OSOM BVBLUE Bacterial Vaginosis | 1 unit | Class II | Ongoing | 27 Mar 2024 |
| Z-1312-2024 | Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL | 3 units | Class II | Ongoing | 27 Mar 2024 |
| Z-1313-2024 | Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST" | 25 units | Class II | Ongoing | 27 Mar 2024 |
| Z-1314-2024 | Abbott Point of Care Control Control i-STAT Level 1 10 X 1.7 mL | 1 unit | Class II | Ongoing | 27 Mar 2024 |
| Z-1315-2024 | Abbott Point of Care Control Control i-STAT Level 3 1.7 mL | 2 units | Class II | Ongoing | 27 Mar 2024 |
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 II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 5Median of the firm: 3
- Events of the firm on the register
- 15
Other events of the firm
Mckesson Medical-Surgical Inc. Corporate Office: all 15 events
Official channels
- FDA enforcement report Z-1311-2024The 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 94024. https://recallregister.com/fda/ii/94024/. 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:
US Nationwide distribution in the states of AZ, PA and TX.
- What quantity of product is in FDA event 94024?
- The event has 5 product records. The first record gives this quantity:
1 unit
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.