TheraSphere Y-90 Microspheres Recalled for Incorrect Radioactivity Labeling
Biocompatibles U.K., Ltd. is recalling one dose of TheraSphere Y-90 Glass Microspheres shipped to Hong Kong because the labeled radioactivity was incorrect.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a significant labeling error regarding radioactivity dosage, which poses a risk of harm if used for treatment, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Biocompatibles U.K., Ltd. is recalling one dose of TheraSphere(R) Yttrium-90 Class Microsphere Injection. The recall involves a specific lot (Lot 1599211) with an expiry date of September 18, 2015. The product was shipped to Hong Kong.
The recall was initiated because the dose was mislabeled regarding its total radioactivity. The product was labeled as containing 10 GBq, but the actual dose was 5 GBq. TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC).
The recall is classified as Class II by the FDA. Patients or healthcare providers who received this specific dose should contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
- Manufacturer
- Biocompatibles U.K., Ltd.
- Affected units
- 64
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 1599211
- Expiry Date: 18SEP2015 (12 days after calibration)
Distribution
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