Food, drugs, devices › Tosoh Smd Inc
Device recall: AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
FDA enforcement event 84299 is a device recall by Tosoh Smd Inc of Grove City, OH, initiated 15 Nov 2019 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 6% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 1 Jul 2020. Initiation: voluntary: firm initiated. Tosoh Smd Inc has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Tosoh Smd Inc, Grove City, OH.
Reason for recall
"The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequate quiet zone can cause the bar code scanner to confuse the bar codes with text or graphics resulting in the scanner ignoring a valid symbol. This results in an error in reading the barcode: Error Code 2220 Unable to read barcode on reagent bottle . In some cases, the quiet zone is too…"
Distribution
"Nationwide Foreign: Columbia, Dominic Republic, Ecuador"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0745-2020 | AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706 | 1012 units | Class III | Terminated | 1 Jan 2020 |
Context
Other enforcement events for Tosoh Smd Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 Dec 2016 | Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as mi | Device | Class II | 1 |
| 15 May 2013 | AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer | Device | Class II | 1 |
All 3 events for Tosoh Smd Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequate quiet zone can cause the bar code scanner to confuse the bar codes with text or graphics resulting in the scanner ignoring a valid symbol. This results in an error in reading the barcode: Error Code 2220 Unable to read barcode on reagent bottle . In some cases, the quiet zone is too…"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Foreign: Columbia, Dominic Republic, Ecuador"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Jul 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.