Z-2067-2018Class II
ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
Tosoh Bioscience Inc / initiated 2018-03-05 / Terminated / root cause: design
Tosoh Bioscience Inc began a recall of ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker on . FDA classified it as Class II and gives the reason as "Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2067-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Tosoh Bioscience Inc
- Product
- ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
- Product code
- LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
- Reason for recall
- Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- The firm TOSOH Bioscience Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 23, 2018 to affected customers. The letter described the product, problem and action to be taken. The customers were instructed to do the following: *Based on our revised labeling, the assays identified in Table 1 should not be used for patients who are being treated with Asfotase Alfa. " For patients that are being treated with Asfotase Alfa, use an alternative test method that does not utilize alkaline phosphatase technology. " Inform all medical professionals that assays utilizing alkaline phosphatase-based technologies must not be used for patients receiving Asfotase Alfa treatment. Continue to use the assays listed in Table 1 for any patients who are not receiving Asfotase Alfa treatment. " Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification via Fax: 1-650-636-8651, Email: [email protected] or Regular mail: 3600 Gantz Rd., Grove City, OH 43123. " Maintain this notification with your laboratory records and forward this information to others who may have received this product. " If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the products identified in the table above, contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. Should you have any questions regarding this medical device recall, please feel free to call (800) 248-6764 or email: [email protected]. Monday - Friday, from 9:00 AM to 5:00 PM (PST).
- Quantity in commerce
- 41105
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
- Product codes and lots
- All Lot Codes
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2065-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2066-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2067-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2068-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2069-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2070-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2071-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2072-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2073-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2074-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2075-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2076-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2077-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2078-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2079-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2080-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2081-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2082-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2083-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2084-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2085-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2086-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2087-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2088-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2089-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2090-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2091-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2092-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2093-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2094-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2095-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2096-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2097-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2098-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2099-2018 | Class II | Terminated | Voluntary: Firm initiated |
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