Device recall: AIA-PACK TPOAb CONTROL SET
Class III FDA enforcement event 76659. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.
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
Tosoh Bioscience, Inc. started this device recall on 8 Feb 2017. The firm address in the FDA record is in South San Francisco, CA. FDA put the recall in Class III. FDA event 76659 has 2 product records. The first FDA enforcement report date is 7 Jun 2017. The record gives the status Terminated, with the termination date 8 Feb 2019.
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.
Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
Recalling firm
Tosoh Bioscience, Inc., South San Francisco, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2168-2017 | AIA-PACK TPOAb CONTROL SET | 15 boxes | Class III | Terminated | 7 Jun 2017 |
| Z-2169-2017 | AIA-PACK TgAb CONTROL SET | 64 boxes | Class III | Terminated | 7 Jun 2017 |
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 2017
- 1,091
- Share of these events in Class III
- 4%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 27
Other events of the firm
Official channels
- FDA enforcement report Z-2168-2017The 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 76659. https://recallregister.com/fda/iii/76659/. 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:
Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX.
- What quantity of product is in FDA event 76659?
- The event has 2 product records. The first record gives this quantity:
15 boxes
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2017 have the same class?
- 4% of the 1,091 device events that started in 2017 are in Class III.